Industry news

• Transition to Single EAEU Market will Save Pharmaceutical Manufacturers from Double Inspections

  03 October 2019 GMP News

  The transition to a single market will save pharmaceutical manufacturers from double inspections and will help optimize the actions of national GMP inspectors – such an opinion was expressed by the panel discussion “Confirmation of GMP compliance as part of the transition to a single market” (Svetlogorsk, All-Russian GMP conference).

• Pre-launch Prep: The Modern Protocol

  02 October 2019 Shaun McMahon / Pharmaceutical Executive

  Whether a pharmaceutical company outsources its sales training programs or develops curriculum in-house, it already knows that thoroughly prepping their brand teams is critical for any successful product launch. But how we access information has changed dramatically in a remarkably short period of time. Not too long ago, training materials were printed, and sales reps would receive stacks of paper to read and review. Today, a large percentage of training is designed for intuitive use, with self-guided movement through curriculum, and accessed via mobile devices (M-learning) or online (E-learning).

• Pharmaceutical Native Advertising

  02 October 2019 Rafael Cosentino / Pharmaceutical Executive

  As engagement with traditional display advertising continues to decline, 70% of individuals want to learn about products via content vehicles rather than through traditional advertising. Nearly 15% of healthcare marketers believe content marketing will make one of the largest commercial impacts in marketing this year (see graphic below), and native ads are an important component.

• Russia Published List of Drugs from 7 Nosologies Program Mandatory for Labeling

  02 October 2019 GMP News

  In the Russian Federation, 27 international generic names of medicines of the list from Seven nosologies program are registered and approved for medical use, the mandatory labeling of which in the Russian Federation was introduced on October 1, 2019.

• New Virtual Reality Platform Offers Life Sciences Industry Training

  01 October 2019 BioPharm International

  A new commercially available educational platform, Virtuosi, by Quality Executive Partners, (QxP), a management consulting firm serving the life sciences industry, offers digital technical courses, virtual reality (VR) interactive experiences, knowledge assessments, curricula management, and reporting. The 31 courses within Virtuosi Series One, Sterile Manufacturing and Microbiology, include 18 VR interactive experiences where learners engage in activities designed to best deliver the intended learning objectives. 

• FDA Gains Approval to Revamp New Drug Review OperationsFDA Gains Approval to Revamp New Drug Review Operations

  01 October 2019 BioPharm International

  After months of planning and explaining, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs. In the works for nearly two years, this effort to modernize and reorganize CDER’s Office of New Drugs (OND) establishes additional new drug review offices and divisions more aligned to assess therapies for interrelated diseases and conditions. In addition, new administrative offices aim to better manage policy development and program management. 

• FDA Encourage Patients to Engage in Medical Device Clinical Investigations

  30 September 2019 GMP News

  At the U.S. Food and Drug Administration we are committed to keeping patients, their families and caregivers at the center of our work and to deepening their involvement in how we review medical device applications. We value patient experience and insights about living with a disease, like diabetes or end-stage renal disease, as well as any impact a medical device – such as a glucose monitor or hemodialysis system – has had in a patient’s diagnosis, treatment and management of that disease. Patient experiences and insight can help us understand the benefits most important to patients and what risks patients may or may not be willing to tolerate.

• FDA Published New Draft Guidance on Electronic Device Submissions

  30 September 2019 GMP News

  Thanks to the FDA Reauthorization Act of 2017 (FDARA), the US Food and Drug Administration (FDA) published a new draft guidance with “both binding and nonbinding provisions” related to electronic submissions for medical devices.

• Russian CDAT and Siemens Signed Agreement on Strategic Partnership

  27 September 2019 GMP News

  The Center for the Development of Advanced Technologies (CDAT), the operator of the Russian information system for digital labeling and tracking of goods, and Siemens signed an agreement on strategic partnership. The document was signed by Andrei Kirillov, General Director of the Center for Digital Technologies, and Zhanna Shalygina, Director of the Digital Production Department of Siemens in Russia.

• Russia Healthcare Spendings to Reach 11.2bn Rubles in 2020

  27 September 2019 GMP News

  The Russian government has approved the draft federal budget for 2019 and the planning period 2020-2021. In 2020, 11.277 billion rubles will be allocated for financing the pharmaceutical and medical industries. The surplus of the federal budget of the Russian Federation in 2020 will amount to 0.9 trillion rubles, in 2021 – 0.6 trillion rubles, and in 2022 – 0.3 trillion rubles. This is stated in the draft budget for 2020 and for the planning period 2021-2022.